Antifungal drug for external use, which has a broad spectrum of antifungal activity. In low concentrations, terbinafine has fungicidal activity against dermatophytes (Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum, Trychophyton tonsurans, Microsporum canis, Epidermophyton floccosum), molds (mainly Candida albicans) and some dimorphs (Pityrosporum orbiculare). Activity against yeast fungi, depending on their species, may be fungicidal or fungistatic.
Terbinafine specifically changes the early stage of sterol biosynthesis occurring in fungi. This leads to ergosterol deficiency and intracellular accumulation of squalene, which causes cell death of the fungus.
Indications
Prevention and treatment of fungal skin infections: foot mycoses (tinea pedis); keratinization, cracking, itching and flaking of the skin caused by foot fungus; inguinal epidermophytosis (tinea craris), fungal lesions of smooth skin of the body (tinea corporis) caused by dermatophytes such as Trichophyton (incl.T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum; yeast skin infections, mainly those caused by Candida fungi (such as Candida albicans), in particular diaper rash; varicolor (Pityriasis versicolor) caused by Pityrosporum orbiculare (Malassezia furfur).
Active ingredient
Terbinafine
Composition
1 g of cream contains:
The active ingredient:
terbinafine hydrochloride 10 mg;
Associates:
benzyl alcohol;
sodium hydroxide; <
sorbitan stearate;
cetyl palmitate;
stearyl alcohol;
cetyl alcohol;
polysorbate 60;
Isopropyl myristate;
purified water.
How to take, the dosage
In adults and children over 12 years of age Lamisil® cream may be used 1 or 2 times a day, depending on the indication. Before using the drug, the affected areas should be thoroughly cleaned and dried. The cream is applied in a thin layer to the affected skin and adjacent areas and lightly rubbed in. In infections accompanied with diaper rash (under the breasts, between the fingers, between the buttocks, in the groin area) the cream can be covered with gauze, especially at night.
With extensive fungal body lesions it is recommended to use the cream in tubes of 30 g.
The average duration of treatment and number of times the preparation is used in case of dermatomycosis of the trunk and shins – 1 week 1 time/day; 1 week 1 time/day in case of dermatomycosis of the feet; 2 weeks 1-2 times/day in case of keratinization, cracks, itching and skin peeling caused by foot fungus; 1 – 2 weeks 1 time/day in case of skin candidiasis; 2 weeks 1-2 times/day in case of lichen planus.
Reduction of clinical manifestations is usually observed during the first days of treatment. In case of irregular use or premature discontinuation of treatment there is a risk of recurrent infection. If there are no signs of improvement after 1-2 weeks of therapy the diagnosis should be verified.
Dosage regimen adjustment of Lamisil® cream in elderly patients is not required.
Interaction
The drug interaction of Lamisil® is currently unknown.
Directions for use
The drug is prescribed with caution in patients with hepatic and/or renal insufficiency, patients with chronic alcoholism, inhibition of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of limb vessels.
Special Instructions
Reduction in the severity of clinical manifestations is usually noted in the first days of treatment. In case of irregular use or its premature termination there is a risk of relapse of the infection.
The drug is intended for external use only.
Avoid contact of the drug with the eyes, as it may cause irritation. In case of accidental contact the eyes should be immediately rinsed with running water. In case of persistent irritation you should consult a doctor.
In case of allergic reactions the drug should be discontinued.
Lamisil® cream for external use contains cetyl alcohol and stearyl alcohol, which may cause local allergic reactions (contact dermatitis).
Synopsis
Cream for external use is white, homogeneous or nearly homogeneous, smooth, with a faint characteristic odor.
Contraindications
Hypersensitivity to terbinafine or to any of the inactive ingredients that make up the drug; breastfeeding period; children under 12 years of age.
Side effects
Definition of side effect frequency (WHO): very common (≥1/10), common (≥1/100 and < 1/10), infrequent (≥1/1000 and < 1/100), rare (≥1/10 000 and < 1/1000), very rare (< 1/10 000), including individual reports.
Immune system: isolated reports – hypersensitivity reactions (rash).
Visually: rare – eye irritation.
Skin: often – skin peeling, itching; infrequent – skin damage, crusting, skin lesions, pigmentation disorders, erythema, burning sensation of the skin; rarely – feeling of dry skin, contact dermatitis, eczema; single reports – rash.
Local reactions: infrequent – pain, pain at the application site, irritation at the application site; rarely – exacerbation of disease symptoms. Itching, peeling of the skin, painful sensations, irritation, changes in skin pigmentation, burning, erythema and crusts may be observed where the drug is applied.
These minor symptoms should be distinguished from hypersensitivity reactions, such as rash, which occur in rare cases and require discontinuation of therapy. In rare cases, the course of the fungal infection may worsen.
If any of these side effects worsen, or if the patient notices any other side effects, you should tell your doctor.
Overdose
No cases of overdose of Lamisil® preparation have been reported.
Pregnancy use
Because clinical experience with Lamisil® cream in pregnant women is very limited, it should not be used unless absolutely necessary. During pregnancy the drug is used only if the expected benefits to the mother exceed the potential risk to the fetus. It is necessary to consult a physician.
In experimental studies terbinafine teratogenic properties have not been identified. To date, no malformations have been reported with Lamisil®.
Terbinafine is excreted with breast milk, so the drug should not be prescribed to nursing mothers. Infants should not be allowed to come into contact with any surface of the skin treated with Lamisil®.
Similarities
Terbinafin-Teva, Exifin, Lamisil, Fungoterbin, Lamisil Dermgel, Terbisil, Binafin, Termicon, Exiter, Terbinafin, Terbix
Weight | 0.025 kg |
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Shelf life | 3 years |
Conditions of storage | At a temperature not exceeding 30 °C (do not freeze). |
Manufacturer | GSC Consumer Healthcare S.A., Switzerland |
Medication form | exterior cream |
Brand | GSC Consumer Healthcare S.A. |
Other forms…
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